Nigeria’s drug regulator says that it has blacklisted an Indian company after it manufactured counterfeit medicines for a Nigerian drugmaker. Moji Adeyeye, a professor who heads the National Agency for Food and Drug Administration and Control (NAFDAC) issued a statement saying that in addition to the blacklist, the agency had delisted the registration number of Pinnalce Health’s Ciproflaxin Tablets BP 500mg which had been registered as C4-0498.
NAFDAC also said that the agency would bar all products manufactured by Mars Remedies PVT Limited of 635 GIDC Estate Waghodia, Vadodara, Gujurat, India from entering Nigeria.
In a letter dated October 9, 2020 and addressed to the Managing Director of Mars Remedies PVT Limited titled: Notice of blacklisting as a manufacturer of substandard and falsified medicines,” the Director-General of NAFDAC, Professor Mojisola Christianah Adeyeye, reiterated the agency’s position of zero tolerance for the preponderance of substandard and falsified medicines in Nigeria in fulfillment of the regulatory obligation of safeguarding the health sector.
Ms Adeyey said that in violation of NAFDAC’s extant laws and regulations, Mars Remedies illegally manufactures different formulations of Ciproflaxin tablets instead of the approved formulation for export to Nigeria.
Ms Adeyeye said that the variation in the formulation of the Ciproflaxin 500mg tablets, which may impact on the product quality and shelf life, was not approved by the agency before the changes were made. She said that this constituted a violation of the NAFDAC Act and that the company had shown a flagrant disregard for compliance with global standards necessary to ensure the production of quality products.
Pinnacle Health is owned by a medical doctor Chizoba Casmir Obi, Clement Ekene Okeke, Kingsley Chukwudi Orji, Amaka Clementina Ubajekwe and Chineze Nwasike Nne. Pinnacle Health did not respond to numerous requests for comment from the Lagos Times newspaper. Mars Remedies also did not respond an emailed request for comment.